Principal / Senior Principal Scientist, DMPK

The role

This person will lead DMPK strategy and oversee bioanalytical work across nonclinical and clinical programs. They will design and oversee PK and PK-PD studies to evaluate delivery technologies and support pharmacology and nonclinical toxicology programs.

What you will do

• Lead DMPK strategy and oversee bioanalytical work across nonclinical and clinical programs
• Oversee development, qualification, and validation of nonclinical and clinical bioanalytical assays
• Design, execute, and oversee PK and PK-PD studies of tRNAs
• Lead PK and PK-PD data analysis and interpretation across mouse, rat, NHP, and human studies
• Manage and qualify CRO and external lab partners
• Support nonclinical toxicology programs in collaboration with internal teams and CROs
• Analyze, interpret, and present DMPK and translational biomarker data
• Author nonclinical sections of regulatory filings and briefing documents
• Serve on the Research Leadership Team
• Manage and develop direct report(s)

Required qualifications

• PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, or related field
• 8+ years of industry experience in DMPK or a closely related function
• Working knowledge of bioanalytical methods (e.g., LC-MS/MS, ligand binding assays, NGS)
• Demonstrated CRO oversight - vendor qualification, study monitoring, data review
• Experience designing and overseeing in vivo nonclinical PK and PK-PD studies for novel delivery modalities
• Hands-on experience with PK and PK-PD data analysis (e.g., noncompartmental analysis) and associated software (e.g., Phoenix WinNonlin)
• Experience in translational or clinical biomarker development, including assay strategy and fit-for-purpose qualification
• Strong scientific writing skills - regulatory documents (e.g., IND nonclinical sections) and internal study reports
• Experience supervising and developing scientists

Nice to have

• LNP experience preferred
• Experience in rare disease or genetic medicine
• Experience with RNA-based therapies
• Familiarity with LNP platform biology and delivery landscape
• Familiarity with GLP toxicology study design and ICH nonclinical guidelines
• Experience operating in a cross-functional leadership role at a clinical-stage biotech
• Experience with ligand binding assays and multiplex immunoassay platforms (e.g., MSD, Luminex)

Benefits

• healthcare coverage
• annual incentive program
• retirement benefits
• broad range of other benefits

About the company

Alltrna is a clinical-stage biotech company advancing tRNA medicines to address shared disease-causing mutations. Founded in 2018 by Flagship Pioneering, Alltrna has built an integrated platform to design, optimize, and deliver engineered tRNA therapeutics.